This Administrative Order aims to achieve the following:
- Ensure the full protection of the rights and safety of human subjects and the integrity of clinical trial data through the adoption and implementation of International Council of Harmonization-Good Clinical Practice (ICH GCP) standards;
- Ensure efficient and effective process for the approval of clinical trials;
- Provide standards and requirements for the regulation and importation of Investigational Products; and
- Strengthen the monitoring of compliance of all organizations, institutions and entities to GCP and other related FDA regulations through regulatory inspections.
Read more:->Administrative Order No.2020-010